Registration Dossier
Registration Dossier
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EC number: 230-262-3 | CAS number: 6994-25-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl 3-amino-1H-pyrazole-4-carboxylate
- EC Number:
- 230-262-3
- EC Name:
- Ethyl 3-amino-1H-pyrazole-4-carboxylate
- Cas Number:
- 6994-25-8
- Molecular formula:
- C6H9N3O2
- IUPAC Name:
- ethyl 3-amino-1H-pyrazole-4-carboxylate
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97/A, 98, 100, 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor induced / rat liver S9
- Test concentrations with justification for top dose:
- 0.05-0.003125 miligram/plate (preliminary study)
10 microgram/plate (main study)
50 microgram/plate (confirmation study) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO: water = 2:1; 10 mg/ml, and diluted with saline to 1 mg/ml
- Justification for choice of solvent/vehicle:
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- deionized two times distillated water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Remarks:
- deionized two times distillated water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Plate incorporation technique.
- Evaluation criteria:
- Well established, according to Guideline.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97/A, 98, 100, 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary experiment: effect of mutagenitity or toxicity was not observed.
Main Study: effect of mutagenitity or toxicity was not observed.
Validation study: S9 concentration increase in S9 mix has not resulted as mutagenic effect. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In the above experimental conditions the substance was not mutagenic in Salmonella.
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